Automated 3D (SonoAVC) Versus 2D Ovarian Follicles Assessment in IVF Cycles: a Randomized Controlled Trial

Infertility Clinical Trial

Official title:

Automated 3D (SonoAVC) vs 2D Ovarian Follicles Assessment in IVF Cycles: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723267
• Other study ID #: rmcavibh-1
• Status: Completed
• Phase: N/A
• First received: July 12, 2012
• Last updated: April 10, 2016
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2016
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Accurate assessment of the size of follicles is important in IVF treatment.Timing of oocyte maturation and subsequent egg collection is largely based on follicle size. An accurate assessment of follicle size and appropriate timing of HCG result in retrieval of more mature oocytes, improved fertilization and higher pregnancy rates. in 3D technology- fter the capturing of a 3D image of an ovary, SonoAVC automatically analyzes the volume dataset, identifies the boundaries of hypoechoic follicles, and provides estimates of their absolute dimensions. These measurements include the largest diameters in three orthogonal planes, the mean follicular diameter (MFD), the volume of the follicle, and the volume-based diameter (d(V)) of the follicle. In the current study the investigators aim to evaluate the use of this automated technique of follicle measurement vs. standard 2D technology on the timing of oocyte maturation and subsequent oocyte retrieval. The investigators speculate that 3D assessment will increase the rate of mature oocyte collection, and eventually will improve other treatment outcomes such as fertilization rate.

Description:

Not desired

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Age:18-39, cycle number 1-4

Exclusion Criteria:

• PCOS

• Endometriosis

• Poor ovarian response

• TESA sperm

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• 3D follicles assessment
3D ultrasound evaluation in IVF treatment (vs 2D ultrasound)
• 2D follicles assessment
2D ultrasound in IVF treatment (vs 3D ultrasound)

Locations

Country	Name	City	State
Israel	IVF Unit, Rabin Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of matured oocytes		one IVF cycle (within two weeks)	No
Secondary	Fertilization rate in ICSI		one IVF cycle/ patient (within two weeks)	No